Comparison of Functional outcomes following Bipolar Transurethral Enucleation versus Bipolar Transurethral Resection of the Prostate in patients with lower urinary tract symptoms due to Prostatomegaly: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
This research proposal from the Department of Urology at AIIMS Patna aims to compare the functional outcomes of Bipolar Transurethral Enucleation of the Prostate and Bipolar Transurethral Resection of the Prostate in patients suffering from lower urinary tract symptoms due to benign prostatic enlargement.
Although TURP is considered the gold standard surgical treatment, it is associated with complications such as bleeding, prolonged catheterization, TUR syndrome, and possible need for repeat procedures, especially in larger prostates. Enucleation techniques have emerged as promising alternatives that may reduce these complications.
This study is designed as a randomized controlled trial (RCT) to evaluate and compare functional outcomes such as maximum urinary flow rate (Q-max), International Prostate Symptom Score (IPSS), post-void residual urine (PVR), quality of life, and complication rates between the two procedures.
The study is significant because there is limited randomized evidence comparing B-TUEP and B-TURP in the Indian population. The results may help determine whether bipolar enucleation can serve as a cost-effective and efficient alternative to TURP without requiring expensive laser equipment, thereby supporting evidence-based surgical decision-making in benign prostatic enlargement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Age more than 50 years and less than 80 years.
- •2.Patients with moderate and severe LUTS(IPSS more than 19) due to prostatomegaly.
- •3.Patient with BOO (Q-max less than 10 ml/s or PVR more than 100 ML or 30 percents of bladder capacity) with prostatomegaly.
- •4.Patients willing to provide written informed consent and comply with follow-up visits.
排除标准
- •1.Clinical or histological evidence of carcinoma prostate.
- •2.Previous prostate or urethral surgery.
- •3.Urethral stricture disease or neurogenic bladder.
- •4.Refusal to participate in the study.
- •5.Patients unfit for surgery.
研究者
satish chandra
AIIMS Patna